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Coulter Corp.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
51
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K993356COULTER HEMATOLOGY ANALYZERS WITH IRF & MRV ANALYSESApril 20, 2000
K991070COULTER Z2 ANALYZERMay 11, 1999
K990327RETICONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMSApril 26, 1999
K990172TETRAONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS WITH CYTO-STAT TETRACHROME CD45-FITC/CD4-RD1/CD8April 13, 1999
K990352COULTER AC T DIFF 2 ANALYZERApril 1, 1999
K984216IMMUNO-TROL CONTROL CELLSMarch 16, 1999
K982167CYTO-STAT TRICHROME CD45-FITC/CD19-RD1/CD3-PC5 MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT TRICHROME November 9, 1998
K982166CYTO-STAT TRICHROME CD45-FITC/CD56-RD1/CD3-PC5 MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT TRICHROME November 5, 1998
K982172CYTO-STAT CD3-FITC/CD56-RDI MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT/COULTER CLONE MSIGGI-RD1/MSIGSeptember 24, 1998
K973634COULTER AC.T DIFF ANALYZEROctober 29, 1997
K971469COULTER ACT TRON CELL CONTROLJune 30, 1997
K964988COULTER AC.T SERIES ANALYZERMarch 6, 1997
K963263TETRAONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS AND CYTO-STAT TERTRACHROME CD45-FITC/CD4-RDI/CD8January 22, 1997
K962768CYTO-STAT TRICHROME CD45-FITC/CD4-RDI/CD3-PC5 MONOCLONAL ANITBODY REAGENT W/ISOTYPIC CONTROLJanuary 6, 1997
K962305CYTO-STAT TRICHROME CD45-FITC/CD8-RD1/CD3-PC5 MONOCLONAL ANTIBODY REAGENT IWTH ISOTYPIC CONTROLJanuary 6, 1997
K964618CYTO-STAT TRICHROME CD8-FITC/CD4-RDI/CD3-PC5 MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT TRICHROME MSDecember 23, 1996
K962988COULTER GEN-S SYSTEMOctober 30, 1996
K961278COULTER STKS ANALYZER WITH CD4 & CD8 LYMPHOCYTE ANALYSISJuly 22, 1996
K954688FLOW-COUNT COULTER FLUOROSPHERESFebruary 29, 1996
K955334COULTER LINEARITY CONTROLFebruary 8, 1996